Astonea Miconazole Nitrate
NDC Package 77338-165-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Astonea Miconazole Nitrate is clean the affected area & dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, & change shoes & socks at least once dailyfor athlete's foot & ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails. Marketed by Astonea Labs Private Limited, this product is identified by NDC 77338-165 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
77338-165-03
Package Description
85 g in 1 BOTTLE, PLASTIC
Product Code
77338-165
11-Digit Billing Format
77338016503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Astonea Miconazole Nitrate
Dosage Form
-
Usage Information
Clean the affected area & dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, & change shoes & socks at least once dailyfor athlete's foot & ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails

Regulatory & Marketing

Labeler Name
Astonea Labs Private Limited
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-19-2022
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 77338-165-03 identifies a specific commercial package of 85 g in 1 bottle, plastic of Astonea Miconazole Nitrate, labeled by Astonea Labs Private Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Astonea Labs Private Limited on August 19, 2022. The current certification is valid through December 31, 2025.

How is this Astonea Labs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77338016503. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
77338-165-03
11-Digit CMS (5-4-2)
77338-0165-03

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.